Visitor Monitoring Drug History: DIMETANE
 
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Label and Approval History

Drug Name: DIMETANE
FDA Application No: (NDA) 010799
Active Ingredient(s): BROMPHENIRAMINE MALEATE
Company: WYETH CONS
 
Label History
 
Labels are not available on this site for DIMETANE, (NDA) 010799
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/14/1998 073Manufacturing Change or Addition  
4/30/1996 071Labeling Revision  
2/6/1996 070Control Supplement  
6/3/1992 069Control Supplement  
1/24/1989 068Control Supplement  
1/24/1989 067Labeling Revision  
3/24/1988 066Control Supplement  
3/17/1988 065Control Supplement  
6/17/1986 064Labeling Revision  
6/10/1986 063Control Supplement  
5/28/1985 062Control Supplement  
6/24/1985 060Control Supplement  
8/17/1984 059Control Supplement  
12/19/1984 058Control Supplement  
4/15/1983 057General Efficacy (MarkIV)  
4/15/1983 056Control Supplement  
8/17/1984 053Control Supplement  
7/10/1986 052Control Supplement  
9/4/1986 051Control Supplement  
6/10/1983 035Labeling Revision  
6/10/1983 034Control Supplement  
8/23/1957 000Approval  
 
Therapeutic Equivalents
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